Health Trials

Sarilumab Efficacy and Safety in Adults With Early Polymyalgia Rheumatica

ConditionPolymyalgia Rheumatica
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorSanofi

About this trial

This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 4, 3-group study to assess whether treatment with sarilumab at either 150 mg q2w (once every two weeks) or at 200 mg q2w, each given with a 52-week prednisone taper, is superior to placebo given with a 52-week prednisone taper in participants with early polymyalgia rheumatica (PMR) and to determine the safety and tolerability of the sarilumab regimens.

The study will consist of the following visits:

Visit 1 (D-42 to D-1): Screening, Visit 2 (D1): Baseline, randomization, first study drug administration, Visit 3 to 12 (Week 2 to Week 52): Treatment period, Visit 13 (Week 52): End of Treatment (EOT) visit, Visit 14 (Week 58): End of Study (EOS) visit.

Eligibility criteria

Qualifiers

Adults ≥50 years with polymyalgia rheumatica according to the EULAR/ACR classification criteria

Meet criteria for newly diagnosed PMR (received ≤6 weeks of corticosteroids prior to randomization) or for early relapsing PMR (initiated corticosteroid treatment within last year, treated with prednisone ≥10 mg/day for ≥ 8 weeks, and experienced flare within prior 12 weeks while receiving ≥5 mg/d prednisone)

Participants must be willing and able to take prednisone of 15 mg/day at randomization

Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

Disqualifiers

Diagnosis of Giant Cell Arteritis (GCA)

Concurrent rheumatoid arthritis, inflammatory arthritis, connective tissue diseases, fibromyalgia

Inadequately treated hypothyroidism

Exclusion related to tuberculosis (TB), invasive opportunistic infections, recurrent or persistent infections including hepatitis B, C or HIV, recurrent herpes zoster or active herpes zoster

Trial design

Treatments tested in this trial

  • Sarilumab
  • Sarilumab
  • Placebo

Treatment groups

300 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Sanofi

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov